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Effectiveness of Ambulatory Transcutaneous Tibial Nerve Stimulation for Overactive Bladder

ConditionsOveractive Bladder (OAB)Urinary Urgency
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSEZGIN

About this trial

The goal of this clinical trial is to learn if using a portable nerve stimulation (TENS) device during daily life works to reduce overactive bladder (OAB) symptoms in adults aged 18 to 65. The main questions it aims to answer are:

* Does using TENS at home during daily activities reduce the number of urgency episodes? * Does this approach improve bladder symptoms and quality of life as much as clinic-based treatment?

Researchers will compare two ways of using TENS applied to the ankle area (tibial nerve stimulation):

* Group 1 (Clinic-based): Participants will visit the clinic twice a week for 2 weeks and receive 30-minute TENS sessions. * Group 2 (Ambulatory): Participants will use a portable TENS device at home during their daily routine when they feel the urge to urinate, over a 2 week period.

Both groups will use the same electrical settings (20 Hz frequency, 200 µs pulse width).

Participants will:

* Complete bladder symptom questionnaires before and after the study * Fill in a 3-day voiding diary to track how often they urinate, urgency episodes, and any leakage * Answer quality of life questions at the start and at 4 weeks

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 to 65 years

Clinical diagnosis of overactive bladder (OAB)

Working in an office setting or spending most of the day at home, suitable for using a portable TENS device

Disqualifiers

Pregnancy

Cardiac pacemaker

Epilepsy

Metal implant in the ankle area

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ambulatory Transcutaneous Tibial Nerve Stimulation

    Device

    Participants will use a portable TENS device at home during daily activities when they experience urgency symptoms over a 2-week period. Two surface electrodes will be placed over the posterior tibial nerve near the inner ankle. Stimulation parameters: 20 Hz frequency, 200 µs pulse width, intensity at the highest comfortable level below motor threshold. Participants will receive training on correct electrode placement and device use at the first clinic visit.

  • Conventional Clinic-Based Transcutaneous Tibial Nerve Stimulation

    Device

    Participants will receive TTNS at the clinic twice per week for 2 weeks (4 sessions total), each lasting 30 minutes. Two surface electrodes will be placed over the posterior tibial nerve near the inner ankle. Stimulation parameters: 20 Hz frequency, 200 µs pulse width, intensity at the highest comfortable level below motor threshold. Sessions will be administered by a trained healthcare professional.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Conventional Clinic-Based TTNSActive comparator 1 intervention
Group B: Ambulatory Self-Administered TTNSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Overactive Bladder Symptom Score (OABSS)

OABSS is a 4-item self-administered questionnaire measuring the frequency of daytime urination, nighttime urination, urgency, and urgency urinary incontinence. Total score ranges from 0 to 15. Higher scores indicate more severe OAB symptoms and worse outcome.

Time frame
Baseline and 4 weeks
2

OAB-V8 (Overactive Bladder - V8 Questionnaire)

Description: OAB-V8 is an 8-item patient-reported questionnaire assessing the bothersomeness of overactive bladder symptoms. Each item is scored from 0 (not at all) to 5 (a very great deal), yielding a total score ranging from 0 to 40. Higher scores indicate greater symptom burden and worse outcome.

Time frame
Baseline and 4 weeks
3

Health-Related Quality of Life - International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB)

The ICIQ-OAB is a patient-reported outcome measure assessing the frequency and bothersomeness of overactive bladder symptoms including daytime urinary frequency, nocturia, urgency, and urgency urinary incontinence. It consists of 4 items, each rated on a symptom frequency scale. Total score ranges from 0 to 16. Higher scores indicate more severe overactive bladder symptoms and worse outcome.

Time frame
Baseline and 4 weeks

Secondary outcomes

1

Patient Satisfaction - Patient Global Impression of Improvement (PGI-I)

Description: The PGI-I is a single-item patient-reported outcome measure assessing the patient's perception of overall improvement following treatment. The scale ranges from 1 to 7, where 1 = "very much better" and 7 = "very much worse." Lower scores indicate greater patient satisfaction and better outcome. The PGI-I is widely used in urological and overactive bladder clinical trials to assess treatment satisfaction.

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SEZGIN

Lead sponsor

Başakşehir Çam & Sakura City Hospital

Sponsor institution

Source ClinicalTrials.gov
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